FOCUS: Functional Recovery and Caregiver Burden Following Surgery in the Elderly

• Sponsor: Ottawa Hospital Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01382251
• Collaborator: Canadian Anesthesiologists' Society (Other)
• Enrollment: 123
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the functional recovery of older ambulatory surgical patients and the impact of the current model of care on the caregivers of these patients. This study will provide unique insight into the challenges patients and their families face following surgery.

The primary objective of this study is to:

1. Assess the impact of ambulatory surgery on functional capacity as assessed by the Système de Mesure de l'Autonomie Fonctionnelle (SMAF) one week and one month following surgery in a population of surgical patients 65 years of age and older.

Secondary objectives are to determine if:

1. Changes in the patient's functional capacity result in increased burden of care as assessed by the Zarit Burden Interview (ZBI) in the patient's primary caregiver.

2. Changes in functional capacity are correlated with decrements in quality of life as assessed by the Short Form 12 (SF12).

3. Changes in functional capacity are correlated with inadequate postoperative analgesia as assessed by the Brief Pain Inventory (BPI).

Condition or Disease	Intervention/Treatment	Phase
Activities of Daily Living; Caregivers; Ambulatory Surgical Procedures

Study Design

• Study Type: Observational
• Actual Enrollment: 123 participants
• Time Perspective: Prospective
• Official Title: Functional Recovery and Caregiver Burden Following Surgery in the Elderly
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Patient Patients undergoing ambulatory surgery
Caregiver Spouse, family members, or friends identified as the patient's primary source of support in the community.

Outcome Measures

Primary Outcome Measures

1. Functional Autonomy Measurement System (SMAF) [Baseline, one week, and one month following surgery]

   29-item scale, each item graded on a four-point scale. 0= independent, 1= needs supervision,2 = needs help, 3 = dependent. Total score ranges from 0 to 87 with higher scores indicating increased disability

Secondary Outcome Measures

1. Zarit Burden Interview (ZBI) [Baseline, one week, and one month following surgery]

   A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for "never" and 4 for "nearly always." Scores range from 0-88 with higher scores indicating increased burden of care.

2. Short Form 12 [Baseline, one week, and one month following surgery]

   A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week. Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life.

3. Brief Pain Inventory (BPI) Functional Interference Score. [Baseline, one week, and one month following surgery]

   Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity. Scores are anchored at 0 for "does not interfere" and 10 for "completely interferes." The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients

• aged 65 years and older

• elective surgery with a planned discharge to the community on the day of the surgical procedure.

• Eligible surgical procedures include: inguinal herniorrhaphy, ventral herniorrhaphy, laparoscopic cholecystectomy,laparoscopic salpingoophorectomy, urethropexy, cystocoele/rectocoele repair, vaginal hysterectomy, arthroscopic debridement (knee, hip, shoulder), arthroscopic repair (knee, hip, shoulder), removal of hardware from lower extremity, foot surgery, and lumbar discectomy.

Caregiver

• spouses, family members, or friends identified as the patient's primary source of support in the community.

Exclusion Criteria:

Patients

• Reside in a nursing home providing professional support services;

• Are unable to complete the study instruments due to cognitive (MMSE <24) or physical impairment;

• Are unable to speak English or French

Caregiver

• Professional caregivers (nurse, personal care assistant, etc) hired to care for the patient;

• Unable to complete the study instruments due to physical impairment;

• Unable to Speak English or French

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ottawa Hospital	Ottawa	Ontario	Canada	K1Y 4E9

Sponsors and Collaborators

• Ottawa Hospital Research Institute
• Canadian Anesthesiologists' Society

Investigators

• Principal Investigator: Gregory L Bryson, FRCPC, Department of Anesthesiology, The Ottawa Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT01382251
• Other Study ID Numbers: 2009390-01H
• First Posted: Jun 27, 2011
• Last Update Posted: Jan 20, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Ottawa Hospital Research Institute: Activities of Daily Living; Caregivers; Ambulatory Surgical Procedures
• Additional relevant MeSH terms: Caregiver Burden

Study Results

Participant Flow

Recruitment Details	Patients > 65 yrs scheduled to undergo elective ambulatory orthopedic or peritoneal surgeries were assessed for eligibility. Each patient must have a partner or adult descendant as primary caregiver. Patient-caregiver dyads were approached in the pre-admission unit. Screening began on 2010-07-01 and the final assessment was completed on 2012-01-04.

Arm/Group Title	Ambulatory Surgery Patients	Ambulatory Surgery Caregivers
Arm/Group Description
Period Title: Overall Study
STARTED	123	123
COMPLETED	102	102
NOT COMPLETED	21	21

Baseline Characteristics

Arm/Group Title	Ambulatory Surgery Patients	Ambulatory Surgery Caregivers	Total
Arm/Group Description	Only patients with caregivers were recruited	Caregivers were recruited with the patients receiving surgery	Total of all reporting groups
Overall Participants	102	102	204
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	30 29.4%	30 14.7%
>=65 years	102 100%	72 70.6%	174 85.3%
Sex: Female, Male (Count of Participants)
Female	54 52.9%	55 53.9%	109 53.4%
Male	48 47.1%	47 46.1%	95 46.6%
Region of Enrollment (participants) [Number]
Canada	102 100%	102 100%	204 100%

Outcome Measures

1. Primary Outcome

Title	Functional Autonomy Measurement System (SMAF)
Description	29-item scale, each item graded on a four-point scale. 0= independent, 1= needs supervision,2 = needs help, 3 = dependent. Total score ranges from 0 to 87 with higher scores indicating increased disability
Time Frame	Baseline, one week, and one month following surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ambulatory Surgery Patients	Ambulatory Surgery Caregivers
Arm/Group Description
Measure Participants	102	102
Baseline	4.0 (5.9)	2.0 (2.9)
One Week Post-op	10.9 (7.6)	NA (NA)
One Month Post-op	6.7 (7.2)	NA (NA)

2. Secondary Outcome

Title	Zarit Burden Interview (ZBI)
Description	A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for "never" and 4 for "nearly always." Scores range from 0-88 with higher scores indicating increased burden of care.
Time Frame	Baseline, one week, and one month following surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ambulatory Surgery Patients	Ambulatory Surgery Caregivers
Arm/Group Description
Measure Participants	0	102
Baseline	9.3 (9.9)
One Week Post-op	8.9 (9.8)
One Month Post-Op	8.6 (10.6)

3. Secondary Outcome

Title	Short Form 12
Description	A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week. Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life.
Time Frame	Baseline, one week, and one month following surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ambulatory Surgery Patients	Ambulatory Surgery Caregivers
Arm/Group Description
Measure Participants	102	102
Mental Component Score (Baseline)	55.3 (7.5)	55.9 (6.6)
Mental Component Score (One Week Post-op)	54.9 (8.8)	54.4 (9.0)
Mental Component Score (One Month Post-Op)	56.2 (7.8)	54.8 (8.0)
Physical Component Score (Baseline)	43.4 (12.7)	50.5 (7.9)
Physical Component Score (One Week Post-op)	35.1 (10.3)	51.2 (8.4)
Physical Component Score (One Month Post-op)	42.7 (11.4)	51.3 (8.9)

4. Secondary Outcome

Title	Brief Pain Inventory (BPI) Functional Interference Score.
Description	Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity. Scores are anchored at 0 for "does not interfere" and 10 for "completely interferes." The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function.
Time Frame	Baseline, one week, and one month following surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ambulatory Surgery Patients	Ambulatory Surgery Caregivers
Arm/Group Description
Measure Participants	102	0
Baseline	1.8 (2.4)
One Week Post-op	2.1 (2.1)
One Month Post-op	1.2 (1.7)

Adverse Events

Time Frame	30 days following surgery
Adverse Event Reporting Description	Adverse event data not collected on caregivers as they did not undergo surgery.
Arm/Group Title	Ambulatory Surgery Patients
Arm/Group Description
All Cause Mortality
	Ambulatory Surgery Patients
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ambulatory Surgery Patients
	Affected / at Risk (%)	# Events
Total	4/102 (3.9%)
Cardiac disorders
Myocardial Infarction	1/102 (1%)	1
Injury, poisoning and procedural complications
Uncontrolled Pain	1/102 (1%)	1
Small Bowel Perforation	1/102 (1%)	1
Nervous system disorders
Transient Ischemic Attack	1/102 (1%)	1
Other (Not Including Serious) Adverse Events
	Ambulatory Surgery Patients
	Affected / at Risk (%)	# Events
Total	0/102 (0%)

Limitations/Caveats

Single center, relatively infrequent assessment, assessment of caregiver burden limited to primary caregiver, majority of caregivers were not employed outside the home.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.